ID

36933

Description

Metformin And Longevity; ODM derived from: https://clinicaltrials.gov/show/NCT02511665

Lien

https://clinicaltrials.gov/show/NCT02511665

Mots-clés

Versions (1)
  1. 22/06/2019 22/06/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 juin 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02511665

Anglais

Eligibility Prostate Cancer NCT02511665

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 or older and willing and able to provide signed informed consent.
Description

Age | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. histologically confirmed adenocarcinoma of the prostate , with a minimum maximal tumour length of greater than 6mm on core biopsy
Description

Adenocarcinoma of prostate | Tumor Length Core biopsy

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1444754
UMLS CUI [2,3]
C1318309
3. no previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy and cryotherapy)
Description

Prior Therapy Absent Prostate carcinoma | Operative Surgical Procedures Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent | Cold Therapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0010412
UMLS CUI [5,2]
C0332197
4. prostate biopsy within 8 weeks from screening which contains sufficient material for baseline molecular marker assessment at guy's and st thomas' nhs foundation trust..
Description

Biopsy of prostate | Material Biological Marker Assessment

Type de données

boolean

Alias
UMLS CUI [1]
C0194804
UMLS CUI [2,1]
C0520510
UMLS CUI [2,2]
C0005516
UMLS CUI [2,3]
C1516048
5. radical prostatectomy is the scheduled treatment of choice
Description

Radical prostatectomy Scheduled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0205539
6. eastern cooperative oncology group (ecog) performance status less than or equal to 0 or 1.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
7. adequate organ function, defined as follows:
Description

Organ function

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
haemoglobin >10.0g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count >1.5x109/l
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >100x109/l
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
renal function, egfr >60ml/min (calculated by cockcroft gault)
Description

Renal function | Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C2924627
ast and/or alt <2.5 x uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
total bilirubin <1.5 x uln
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
8. able to swallow the drug and comply with study requirements.
Description

Able to swallow Oral medication | Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a current or historical diagnosis of type one or two diabetes and/or have ever received metformin
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Metformin

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0025598
2. patients with hypersensitivity to any of the components of metformin or placebo tablet
Description

Hypersensitivity Metformin Component | Hypersensitivity Placebo Oral Tablet Component

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1249327
UMLS CUI [2,3]
C1705248
3. history of or conditions associated with lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia
Description

Condition Associated with Lactic Acidosis | Shock | Pulmonary Insufficiency | Alcoholic Intoxication, Chronic | Condition Associated with Hypoxemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0001125
UMLS CUI [2]
C0036974
UMLS CUI [3]
C0034088
UMLS CUI [4]
C0001973
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0700292
4. patients with chronic liver disease, severe cardiovascular impairment, cardiac failure, recent myocardial infarction, severe peripheral vascular disease or renal impairment (egfr <60ml/min as measured by cockcroft gault)
Description

Chronic liver disease | Severe cardiovascular impairment | Heart failure | Myocardial Infarction | Peripheral Vascular Disease Severe | Renal Insufficiency | Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C2080705
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0085096
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C1565489
UMLS CUI [7,1]
C3811844
UMLS CUI [7,2]
C2924627
5. patients with acute severe disorders, for example infections with fever, pancreatitis, trauma, dehydration or reduced diet (<1000kcal or 4200kj per day)
Description

Severe disorder | Febrile infection | Pancreatitis | Trauma | Dehydration | Reduced diet

Type de données

boolean

Alias
UMLS CUI [1]
C1836348
UMLS CUI [2]
C0948233
UMLS CUI [3]
C0030305
UMLS CUI [4]
C3714660
UMLS CUI [5]
C0011175
UMLS CUI [6]
C0012167
6. other active malignancy over the last five years that has required systemic therapy, excluding:
Description

Cancer Other Requirement Systemic therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
adjuvant therapy in the curative setting
Description

Exception Adjuvant therapy Curative

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C1276305
non-melanoma skin cancer
Description

Exception Skin carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0699893
superficial transitional cell carcinoma (cis-t1)
Description

Exception Transitional Cell Carcinoma Superficial TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007138
UMLS CUI [1,3]
C0205124
UMLS CUI [1,4]
C3258246
7. current enrolment in an investigational drug or device study or participation in such a study within 30 days of signing consent.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
8. any subjects who is able to father a child and does not agree to use barrier protection, in the form of a condom ,for the duration of the trial and for 16 weeks after the last study drug administration.
Description

Male fertility Barrier Contraception Unwilling | Male fertility Condom use Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C1955321
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C1955321
UMLS CUI [2,2]
C0679782
UMLS CUI [2,3]
C0558080
Retour au début de la page

Similar models

Eligibility Prostate Cancer NCT02511665

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. age 18 or older and willing and able to provide signed informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Adenocarcinoma of prostate | Tumor Length Core biopsy
Item
2. histologically confirmed adenocarcinoma of the prostate , with a minimum maximal tumour length of greater than 6mm on core biopsy
boolean
C0007112 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
Prior Therapy Absent Prostate carcinoma | Operative Surgical Procedures Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent | Cold Therapy Absent
Item
3. no previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy and cryotherapy)
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0010412 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Biopsy of prostate | Material Biological Marker Assessment
Item
4. prostate biopsy within 8 weeks from screening which contains sufficient material for baseline molecular marker assessment at guy's and st thomas' nhs foundation trust..
boolean
C0194804 (UMLS CUI [1])
C0520510 (UMLS CUI [2,1])
C0005516 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
Radical prostatectomy Scheduled
Item
5. radical prostatectomy is the scheduled treatment of choice
boolean
C0194810 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status less than or equal to 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
7. adequate organ function, defined as follows:
boolean
C0678852 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin >10.0g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >1.5x109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >100x109/l
boolean
C0032181 (UMLS CUI [1])
Renal function | Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
renal function, egfr >60ml/min (calculated by cockcroft gault)
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C2924627 (UMLS CUI [2,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and/or alt <2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin <1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Able to swallow Oral medication | Protocol Compliance
Item
8. able to swallow the drug and comply with study requirements.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Metformin
Item
1. patients with a current or historical diagnosis of type one or two diabetes and/or have ever received metformin
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Hypersensitivity Metformin Component | Hypersensitivity Placebo Oral Tablet Component
Item
2. patients with hypersensitivity to any of the components of metformin or placebo tablet
boolean
C0020517 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1249327 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Condition Associated with Lactic Acidosis | Shock | Pulmonary Insufficiency | Alcoholic Intoxication, Chronic | Condition Associated with Hypoxemia
Item
3. history of or conditions associated with lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia
boolean
C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0001125 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2])
C0034088 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])
Chronic liver disease | Severe cardiovascular impairment | Heart failure | Myocardial Infarction | Peripheral Vascular Disease Severe | Renal Insufficiency | Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
4. patients with chronic liver disease, severe cardiovascular impairment, cardiac failure, recent myocardial infarction, severe peripheral vascular disease or renal impairment (egfr <60ml/min as measured by cockcroft gault)
boolean
C0341439 (UMLS CUI [1])
C2080705 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1565489 (UMLS CUI [6])
C3811844 (UMLS CUI [7,1])
C2924627 (UMLS CUI [7,2])
Severe disorder | Febrile infection | Pancreatitis | Trauma | Dehydration | Reduced diet
Item
5. patients with acute severe disorders, for example infections with fever, pancreatitis, trauma, dehydration or reduced diet (<1000kcal or 4200kj per day)
boolean
C1836348 (UMLS CUI [1])
C0948233 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0011175 (UMLS CUI [5])
C0012167 (UMLS CUI [6])
Cancer Other Requirement Systemic therapy
Item
6. other active malignancy over the last five years that has required systemic therapy, excluding:
boolean
C1707251 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Exception Adjuvant therapy Curative
Item
adjuvant therapy in the curative setting
boolean
C1705847 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Exception Skin carcinoma
Item
non-melanoma skin cancer
boolean
C1705847 (UMLS CUI [1,1])
C0699893 (UMLS CUI [1,2])
Exception Transitional Cell Carcinoma Superficial TNM clinical staging
Item
superficial transitional cell carcinoma (cis-t1)
boolean
C1705847 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
7. current enrolment in an investigational drug or device study or participation in such a study within 30 days of signing consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Male fertility Barrier Contraception Unwilling | Male fertility Condom use Unwilling
Item
8. any subjects who is able to father a child and does not agree to use barrier protection, in the form of a condom ,for the duration of the trial and for 16 weeks after the last study drug administration.
boolean
C1955321 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1955321 (UMLS CUI [2,1])
C0679782 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Retour au début de la page 

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